BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLP TRACK END

    MDR report key: 20684341 · Received November 14, 2024

    Report

    Report Number
    3023268435-2024-00019
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    November 1, 2024
    Report Date
    February 21, 2025
    Manufacturer
    ABBOTT AUTOMATION SOLUTIONS GMBH
    Product Code
    JQP
    UDI-DI
    00380740187200
    PMA / PMN Number
    K213486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE ABBOTT AUTOMATION SOLUTIONS (AAS) TECHNICAL GROUP PERFORMED AN INVESTIGATION BASED ON THE COMPLAINT INFORMATION. THE AAS TEAM DETERMINED THAT THE PCB SHOWED EVIDENCE OF MELTING AROUND THE ACTUATOR AND BURN MARKS. INVESTIGATION SHOWED THAT THE ISSUE WAS MOST LIKELY CAUSED BY SERUM AND BLOOD SPILL ONTO THE BOARD WHERE POWER CONNECTIONS WERE MADE BETWEEN SOME OF THE OTHER COMPONENTS. FURTHERMORE, IT WAS ALSO IDENTIFIED THAT THE BOARD WAS AN OLDER REVISION OF THE DC DISTRIBUTION BASE. THIS MEANT THAT THE BOARD WAS NOT EQUIPPED WITH THE ADDITIONAL POLYFUSES USED TO SEPARATE THE POWER DISTRIBUTION ON THE BOARD, WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR. REVIEW OF TICKETS DID NOT FIND ANY OTHER COMPLAINTS RELATED TO THE CURRENT ISSUE FOR GLP CROSSSWITCH (LIST NUMBER 06R20-01) IN A 12-MONTH PERIOD. BASED ON THE INVESTIGATION, A DEFICIENCY WAS IDENTIFIED AS THE GLP CROSSSWITCH FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. THE ISSUE ONLY AFFECTS PARTS RECEIVED PRIOR TO JUNE 2019. REVIEW OF DISTRIBUTION OF THE IMPACTED PARTS INDICATED NONE OF THE AFFECTED PARTS WERE RECEIVED WITHIN NORTH AMERICA. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, GLP TRACK END, LIST NUMBER 06Q42-01, WHICH HAS A SAME/SIMILAR COMPONENT OF THE MODULAR GLP TRACK SYSTEM REGISTERED IN THE US, LIST NUMBER 04Z96-51 AND 510K NUMBER K213486.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED DISTRIBUTOR (SYSMEX) WHO INFORMED US THAT BURNING MARKS ON THE PCB (PRINTED CIRCUIT BOARD BASICALLY CONTROLLER BOARD) OF THE PART AND THE HOUSING OF GLP TRACK CROSS SWITCH. THE VISIBLE SMOKE OR FIRE FROM CONTROLLER BOARD OF THE CROSS SWITCH, VISIBLE THROUGH MELTING/COLOR CHANGING PLASTIC HOUSING OF GLP TRACK. THERE WAS NO DAMAGED TO FACILITY OR USER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM TO USER REPORTED. NO ADDITIONAL IMPACT TO USER SAFETY WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED (B)(4) (DISTRIBUTOR) WHO INFORMED ABBOTT THAT THE GLP CROSS-SWITCH OF THE GLP SYSTEMS TRACK CAUGHT ON FIRE. IT WAS FURTHER REPORTED THAT THERE WAS VISIBLE SMOKE OR FIRE ON THE CONTROLLER BOARD OF THE CROSS SWITCH AND THAT MELTING/COLOR CHANGES WERE NOTED AROUND THE PLASTIC HOUSING. THERE WAS NO DAMAGED TO FACILITY OR USER. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM TO USER REPORTED. NO ADDITIONAL IMPACT TO USER SAFETY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204840 GLP TRACK END CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT AUTOMATION SOLUTIONS GMBH 00380740187200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GLP CROSSSWITCH, 06R20-01, UNKNOWN